24 Participants Needed

CABA-201 for Inflammatory Myopathies

Recruiting at 27 trial locations
CB
Overseen ByCabaletta Bio
Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Cabaletta Bio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Cabaletta Bio

Are You a Good Fit for This Trial?

This trial is for adults aged 18-65 with active idiopathic inflammatory myopathy (IIM), including conditions like dermatomyositis and antisynthetase syndrome. Participants must have evidence of ongoing disease despite treatment, shown by muscle weakness or tests like MRI. Excluded are those with severe reactions to the study drugs, active infections needing treatment, major organ issues, previous CAR T cell therapy, or any transplants.

Inclusion Criteria

I experience muscle weakness.
My condition is active despite treatment, shown by tests like MRI or high CK levels.
I have been diagnosed with a muscle condition due to specific antibodies in my blood.
See 1 more

Exclusion Criteria

I am currently being treated for an infection.
I cannot undergo leukapheresis due to health reasons.
I have received CAR T cell therapy before.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preconditioning

Participants receive preconditioning with fludarabine and cyclophosphamide

1 week

Treatment

Participants receive a single infusion of CABA-201

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

156 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CABA-201
Trial Overview The trial is testing CABA-201 after patients receive fludarabine and cyclophosphamide preconditioning. It's an open-label study which means everyone knows they're getting the experimental treatment and there's no placebo group.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CABA-201Experimental Treatment1 Intervention
DM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with DM. ASyS Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with ASyS. IMNM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with IMNM. JIIM Cohort: Infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide preconditioning in subjects with JIIM.

CABA-201 is already approved in United States for the following indications:

🇺🇸
Approved in United States as CABA-201 for:
  • None approved; under investigation for systemic lupus erythematosus, myositis, systemic sclerosis, myasthenia gravis, and pemphigus vulgaris

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cabaletta Bio

Lead Sponsor

Trials
6
Recruited
140+
Unbiased ResultsWe believe in providing patients with all the options.
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